Philips Azurion X-ray systems recalled for cold restart delays
Philips is recalling Azurion interventional fluoroscopic X-ray systems because a cold restart may take up to 7 minutes, potentially delaying treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries are reported. The hazard is a delay in treatment due to a software restart issue, which fits the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America, LLC is recalling 834 units of Philips Azurion interventional fluoroscopic X-ray systems equipped with software version R1.2. The affected models include the Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, and Azurion 7 M20 (models 722063, 722064, 722067, 722068, 722078, and 722079). These systems are used for image guidance in diagnostic, interventional, and minimally invasive surgery procedures, including vascular, non-vascular, cardiovascular, and neuro procedures, as well as cardiac imaging applications.
The recall is due to a software issue where the cold restart of the system may take up to 7 minutes if the system has been connected to the mains power supply for more than 50 days. This extended restart time may result in a delay of treatment. The affected units were distributed nationwide in the United States and in numerous foreign countries, including Canada, Australia, and various nations in Europe, Asia, and the Middle East.
Healthcare facilities should contact Philips North America, LLC for instructions on how to resolve the issue. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The…
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 834
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version R1.2
Distribution
Distributed nationwide across the United States.
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